MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 1; CEMENTLESS HIP STEM

Model Number	01.18.241
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29.01.2020: lot 161475: (b)(4) items manufactured and released on 22-giu-2016.Expiration date: 2021-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Clinical evaluation performed by medical affairs director: two years after primary tha the stem is removed in a patient with a very narrow canal for lack of osseointegration.This is normally an individual reaction to the implant: an individual patient's physiology did not accept the foreign body.Heterotopic ossifications are visible suggesting that some metabolic disorder may have troubled bone formation processes, but no information is available about this condition.
Event or Problem Description
Revision surgery performed 2 years after the primary due to a lack of osseointegration.The stem and the head were revised.

• Brand Name: STEM: AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 1
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9710935
• Report Number: 3005180920-2020-00062
• Device Sequence Number: 3650375
• Product Code: LZO
• UDI-Device Identifier: 07630030804663
• UDI-Public: 07630030804663
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 01.18.241
• Device Catalogue Number: 01.18.241
• Device Lot Number: 161475
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 61 YR